How does exclusivity differ from a patent?

Exclusivity is a period during which a drug manufacturer can market a new drug without competition from generic versions, while a patent is a legal right that protects a company's invention or product from being made, used, or sold by others for a certain period.

The correct choice emphasizes that exclusivity is granted only upon FDA approval. This means that once a drug has received approval from the FDA, the manufacturer is given a certain period of market exclusivity that prevents competitors from marketing generic versions of the drug. This exclusivity begins after the FDA has evaluated the safety and effectiveness of the drug, cementing its status in the marketplace as a unique product.

In contrast, a patent does not rely on FDA approval to exist; it is issued by the U.S. Patent and Trademark Office based on the invention's novelty, usefulness, and non-obviousness. Thus, a patent can exist before FDA approval, which differentiates it significantly from exclusivity.

Understanding this distinction is important for pharmaceutical representatives because it affects how drugs are marketed and when competitors can enter the market with generics.